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TOPIRAMATE ROSEMONT 20 MG / ML ORAL SUSPENSION - patient leaflet, side effects, dosage

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Patient leaflet - TOPIRAMATE ROSEMONT 20 MG / ML ORAL SUSPENSION

Topiramate Rosemont 20mg/ml Oral Suspension

Read all of this leaflet carefully before you start taking this medicine – because it contains important information for you.

n Keep this leaflet. You may need to read it again.

n If you have any further questions, ask your doctor or pharmacist.

n This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

n If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What Topiramate Rosemont is and what it is used for

  • 2. What you need to know before you take Topiramate Rosemont

  • 3. How to take Topiramate Rosemont

  • 4. Possible side effects

  • 5. How to store Topiramate Rosemont

  • 6. Contents of the pack and other information

1. what topiramate rosemont is and what it is used for

The name of your medicine is Topiramate Rosemont 20mg/ml Oral Suspension. In this leaflet the shorter name topiramate is used. Topiramate belongs to a group of medicines called anti-epileptics.

Topiramate can be used:

n alone to treat seizures in adults and children over age 6

n with other medicines to treat seizures in adults and children aged 2 years and above n to prevent migraine headaches in adults.

2. what you need to know before you take topiramate rosemont

Do not take topiramate if:

n you are allergic to topiramate or any of the other ingredients of this medicine (listed in Section 6).

n for migraine prevention, if you are pregnant or if you are a woman of childbearing potential unless you are using effective contraception (see section ‘pregnancy and breast-feeding’ for further information). You should talk to your doctor about the best kind of contraception to use while you are taking topiramate.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking topiramate.

Warnings and precautions

Talk to your doctor or pharmacist before taking topiramate if:

n you have kidney problems, especially kidney stones or are getting kidney dialysis

n you have a history of blood and body fluid abnormality (metabolic acidosis)

n you have liver problems

n you have eye problems, especially glaucoma

n you have a growth problem

n you are on a high fat diet (ketogenic diet)

n you are taking topiramate to treat epilepsy and you are pregnant or a woman of childbearing potential (see section ‘pregnancy and breast-feeding’ for further information).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking topiramate.

It is important that you do not stop taking your medicine without first consulting your doctor.

You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramate Rosemont.

You may lose weight if you use topiramate so your weight should be checked regularly when using this medicine. If you are losing too much weight or a child using this medicine is not gaining enough weight, you should consult your doctor.

A small number of people being treated with antiepileptic medicines such as topiramate have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Topiramate can cause serious skin reactions, tell your doctor immediately if you develop a skin rash and/or blisters (see also section 4 ’Possible side effects’).

Topiramate may in rare cases cause high levels of ammonia in the blood (seen in blood tests) which can lead to a change in brain function, especially if you are also taking a medicine called valproic acid or sodium valproate. Since this may be a severe condition, tell your doctor immediately if the following symptoms occur (see also section 4 ‘Possible side effects’): n difficulty thinking, remembering information, or solving problems n being less alert or aware n feeling very sleepy with low energy

At higher doses of topiramate, the risk of developing these symptoms may increase.

Other medicines and topiramate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topiramate and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or topiramate will have to be adjusted.

Especially, tell your doctor or pharmacist if you are taking:

n other medicines that impair or decrease your thinking, concentration, or muscle coordination (e.g., central nervous system depressant medicines such as muscle relaxants and sedatives)

n birth control pills. Topiramate may make your birth control pills less effective. You should talk to your doctor about the best kind of contraception to use while you are taking topiramate.

Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and topiramate.

Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

Other medicines you should discuss with your doctor or pharmacist include other anti-epileptic medicines, risperidone, lithium, hydrochlorothi­azide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St. John's wort (Hypericum perforatum) (a herbal preparation used to treat depression) and warfarin used to thin the blood.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using topiramate.

Topiramate with food, drink and alcohol

n Topiramate can be taken with or without food.

n Drink plenty of fluids during the day to prevent kidney stones while taking topiramate.

n You should avoid drinking alcohol when taking topiramate.

Pregnancy and breast-feeding

Migraine prevention:

Topiramate can harm an unborn baby. You must not use topiramate if you are pregnant. You must not use Topiramate for migraine prevention if you are a woman of childbearing potential unless you are using effective contraception. Talk to your doctor about the best kind of contraception and whether topiramate is suitable for you. Before the start of treatment with topiramate a pregnancy test should be performed.

Treatment of epilepsy:

If you are a woman of childbearing potential you should talk to your doctor about other possible treatments instead of topiramate. If the decision is made to use topiramate, you should use effective contraception. Talk to your doctor about the best kind of contraception to use while you are taking topiramate. Before the start of treatment with topiramate a pregnancy test should be performed.

Talk to your doctor if you wish to become pregnant.

As with other anti-epileptic medicines, there is a risk of harm to the unborn child if topiramate is used during pregnancy. Make sure you are very clear about the risks and the benefits of using topiramate for epilepsy during pregnancy.

n If you take topiramate during pregnancy, your baby has a higher risk for birth defects, particularly, cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth). Newborn boys may also have a malformation of the penis (hypospadia). These defects can develop early in pregnancy, even before you know you are pregnant.

n If you take topiramate during pregnancy, your baby may be smaller than expected at birth. Talk to your doctor if you have questions about this risk during pregnancy.

n There may be other medicines to treat your condition that have a lower risk of birth defects.

n Tell your doctor straight away if you become pregnant while taking topiramate. You and your doctor should decide if you will continue to take topiramate while you are pregnant.

Breast-feeding

The active substance in Topiramate Rosemont (topiramate) passes into breast milk. Effects have been seen in breastfed babies of treated mothers, including diarrhoea, feeling sleepy, feeling irritable, and poor weight gain. Therefore, your doctor will discuss with you whether you abstain from breast-feeding or whether to abstain from treatment with topiramate. Your doctor will take into account the importance of the medicine to the mother and the risk for the baby. Mothers who breast-feed while taking topiramate must tell the doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness and vision problems may occur during treatment with topiramate. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate Rosemont contains sodium methyl and sodium ethyl hydroxybenzoate, glycerol, benzoic acid and sodium:

n sodium methyl (E219) and sodium ethyl hydroxybenzoate (E215). May cause allergic reactions (possibly delayed).

n glycerol (E422). This may cause headache, stomach upset and diarrhoea.

n benzoic acid (0.001 mg per 1 ml dose), which may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

n sodium (E210). This medicine contains 4.29 mg sodium (main component of cooking/table salt) in each 1 ml dose.

This is equivalent to 0.2% of the recommended maximum daily dietary intake of sodium for an adult.

3. how to take topiramate rosemont